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Scholar Rock Holding Corporation develops biologic therapies for spinal muscular atrophy and other rare, severe, and debilitating neuromuscular diseases through its myostatin biology platform. Its principal program, apitegromab, is an anti-myostatin therapy being developed for children and adults with SMA, and its pipeline also includes subcutaneous apitegromab and SRK-439.
Recurring company updates include FDA regulatory activity for apitegromab, manufacturing and fill-finish matters tied to the program, quarterly financial results, cash and financing activity such as debt and at-the-market equity programs, and Nasdaq inducement equity grants for new employees. Scholar Rock also reports investor-conference participation and pipeline commentary related to anti-myostatin biology.
Scholar Rock (SRRK) received FDA approval for ISEMBYLD (apitegromab-mstn) on September 11, 2026, as the first and only muscle-targeted treatment for spinal muscular atrophy (SMA) in adults and children ≥2 years who are already on an SMN2-targeted therapy.
Approval is based on the Phase 3 SAPPHIRE trial, where the recommended 10 mg/kg dose achieved a 2.2‑point mean HFMSE motor-function improvement versus SMN2 therapy alone at one year (nominal p = 0.0121; ages 2–12, n = 103). A ≥3‑point HFMSE gain occurred in 34.2% of ISEMBYLD patients vs. 13.5% on placebo (odds ratio 3.8; nominal p = 0.0125). The safety database includes 500+ individuals, with most SAPPHIRE participants entering the ONYX extension. The most common adverse reactions were respiratory and viral infections, vomiting, cough, headache, gastroenteritis, pharyngitis, hypersensitivity, and a higher fracture rate (9% vs. 2% placebo).
U.S. commercial launch is underway, product will ship in the coming days, and the company has been granted a Rare Pediatric Disease Priority Review Voucher. The Scholar Rock Supports™ program is active to assist with access, reimbursement, and infusion logistics, including hospital, home, or infusion-center administration.
Scholar Rock (SRRK) received FDA Fast Track and Orphan Drug designations for apitegromab in facioscapulohumeral muscular dystrophy (FSHD) and has begun dosing participants in the Phase 2 FORGE trial. Apitegromab is an investigational fully human monoclonal antibody designed to inhibit myostatin activation in skeletal muscle.
FORGE is a randomized, double-blind, placebo-controlled, multi-center Phase 2 study in approximately 60 adults with genetically confirmed FSHD, randomized 1:1 to apitegromab 10 mg/kg or placebo, administered intravenously every four weeks for 52 weeks. The primary endpoint is percent change from baseline in total lean muscle volume by MRI at Week 52, with secondary endpoints including lean muscle volume at Week 24, changes in muscle fat fraction, and safety and tolerability. The FSHD program is supported by translational preclinical data in a mouse model showing increased muscle mass, strength, and endurance.
Scholar Rock (NASDAQ: SRRK) announced that management will participate in two investor events: the Cantor 2026 Global Healthcare Conference with a fireside chat at 8:00 a.m. ET on Wednesday, September 9, 2026, and the Citi 2026 BioPharma Back to School Conference with a fireside chat at 9:20 a.m. ET on Thursday, September 10, 2026, both in New York, NY. Live webcasts and 90-day replays will be available via the Investors section of the Scholar Rock website.
Scholar Rock (NASDAQ: SRRK) reported global regulatory progress for apitegromab for spinal muscular atrophy (SMA). Under FDA guidance, Catalent Indiana was removed as a commercial fill-finish facility from the U.S. BLA, which continues under review using an alternate facility ahead of the September 30, 2026 PDUFA date.
The company withdrew its European MAA after FDA classified Catalent Indiana’s April 2026 inspection as Official Action Indicated and plans to resubmit using the alternate facility. In Japan, PMDA agreed no additional clinical studies are required, enabling a planned apitegromab JNDA submission by year-end 2026.
Scholar Rock (NASDAQ: SRRK) granted inducement equity awards covering a total of 51,947 shares of common stock to twelve newly hired employees under its 2022 Inducement Equity Plan, in accordance with Nasdaq Listing Rule 5635(c)(4).
The awards comprise stock options for 14,889 shares with an exercise price of $51.89 (the August 10, 2026 closing price) and 37,058 restricted stock units. Options vest 25% on the first anniversary of each employee’s start date, with the remaining 75% vesting in 12 equal quarterly installments, while RSUs vest in four equal annual installments, all subject to continued service.
Scholar Rock (NASDAQ: SRRK) reported that FDA review of its apitegromab Biologics License Application for treating children and adults with spinal muscular atrophy is now progressing solely with the company’s second U.S.-based fill-finish facility. The BLA remains under review with a Prescription Drug User Fee Act (PDUFA) action date of September 30, 2026.
Following notification from Catalent Indiana that FDA classified its April 2026 inspection as Official Action Indicated (OAI), Scholar Rock, under FDA guidance, will remove that site from the BLA. A pre-agreed data package for the second facility was submitted ahead of schedule, review is advancing, and commercial vials are ready pending packaging and labeling. Scholar Rock is also engaging with the EMA to include the second facility in its apitegromab MAA.
Scholar Rock (NASDAQ: SRRK) reported second quarter 2026 net loss of $109.9 million (basic and diluted net loss per share $0.84), compared with a net loss of $110.0 million, or $0.98 per share, in the prior-year quarter. The company recorded no revenue in either period.
Research and development expense was $58.2 million and general and administrative expense was $50.7 million. Cash, cash equivalents, and marketable securities totaled $492.1 million as of June 30, 2026, including $62.8 million in net proceeds from an at-the-market program.
The apitegromab BLA for SMA remains under FDA review with a September 30, 2026 PDUFA date, supported by two fill-finish facilities and ample commercial supply on hand. EMA review of the apitegromab MAA is ongoing. Scholar Rock also initiated the Phase 2 FORGE trial in FSHD, continues enrollment in the OPAL SMA study, and is progressing a Phase 1 trial of SRK-439.
Scholar Rock (NASDAQ: SRRK) announced that its management will present at the Canaccord Genuity 46th Annual Growth Conference in Boston, MA on Wednesday, August 12, 2026 at 1:30 p.m. ET. A live webcast and 90-day replay will be accessible via the Investors section of the company’s website.
Scholar Rock (NASDAQ: SRRK) updated the expected timing of the CHMP opinion on its apitegromab marketing authorisation application (MAA) for treating children and adults with spinal muscular atrophy (SMA). The EMA review includes the Catalent Indiana fill-finish facility and is awaiting the FDA’s post-inspection classification update following an April 2026 site inspection.
If the FDA reclassifies Catalent Indiana, a CHMP opinion is expected later in 2026. If not, Scholar Rock plans to work with the EMA to advance the MAA using its second fill-finish facility, already included in the apitegromab BLA under FDA review with a September 30, 2026 PDUFA date.
Scholar Rock (NASDAQ: SRRK) announced inducement equity awards covering an aggregate of 118,586 shares of common stock granted to eleven newly hired employees under its 2022 Inducement Equity Plan. The grants consist of stock options for 33,987 shares and restricted stock units (RSUs) for 84,599 shares.
According to Scholar Rock, the inducement stock options have an exercise price of $54.70, equal to the July 13, 2026 closing price. Options vest 25% on the first anniversary of each employee’s start date, with the remaining 75% vesting in 12 equal quarterly installments; RSUs vest in four equal annual installments, all subject to continued service.